ISO 9001 Lead Implementer Training in Osaka

ISO 9001 Lead Implementer Training Course Outline

Module 1: Introduction

• Scope
• Normative References
• Terms and Definitions

Module 2: Context of the Organisation

• Understanding the Organisation and Its Context
• Understanding the Needs and Expectations of Interested Parties
• Determining the Scope of the Quality Management System
• Quality Management System

Module 3: Leadership

• Leadership and Commitment
• Quality Policy
• Roles, Responsibilities and Authorities

Module 4: Planning

• Actions to Address Risks and Opportunities
• Quality Objectives and Planning to Achieve Them
• Planning of Changes

Module 5: Support

• Resources
• Competence
• Awareness
• Communication
• Documented Information

Module 6: Operation

• Operational Planning and Control
• Requirements for Products and Services
• Design and Development of Products and Services
• Control of Externally Provided Processes, Products and Services
• Production and Service Provision
• Release of Products and Services
• Control of Nonconforming Outputs

Module 7: Performance Evaluation

• Monitoring, Measurement, Analysis and Evaluation
• Internal Audit
• Management Review

Module 8: Improvement

• Continual Improvement
• Nonconformity and Corrective Action

Module 9: Fundamentals of Quality Management System Auditing

• Purpose and Objectives of QMS Auditing
• First-Party, Second-Party and Third-Party Audits
• Quality Management System Audit Concepts
• Role of Auditing in QMS Effectiveness

Module 10: Principles of Auditing

• Integrity and Professional Conduct
• Fair Presentation
• Due Professional Care
• Confidentiality and Independence

Module 11: Evidence-Based Auditing

• Evidence-Based Audit Approach
• Objective Evidence and Audit Evidence
• Verification and Corroboration of Evidence
• Sufficiency and Appropriateness of Audit Evidence

Module 12: Risk-Based Auditing

• Risk-Based Audit Thinking
• Identifying Audit Risks and Opportunities
• Determining Audit Priorities
• Integrating Risk Considerations into Audit Activities

Module 13: Audit Programme Management

• Establishing Audit Programme Objectives
• Determining Audit Programme Scope
• Audit Programme Resources and Responsibilities
• Monitoring and Reviewing the Audit Programme

Module 14: Audit Programme Planning

• Determining Audit Frequency and Priorities
• Considering Process Importance
• Considering Previous Audit Results
• Addressing Changes Affecting the Audit Programme

Module 15: Auditor Competence

• Auditor Knowledge and Skills
• QMS and Audit Competence
• Maintaining Auditor Competence
• Evaluating Auditor Performance

Module 16: Lead Auditor Responsibilities

• Responsibilities of the Lead Auditor
• Managing Audit Team Activities
• Coordinating Audit Team Communication
• Maintaining Objectivity and Impartiality

Module 17: Audit Team Selection and Management

• Selecting Appropriate Auditors
• Assigning Audit Responsibilities
• Managing Auditor Independence
• Coordinating Multi-Auditor Activities

Module 18: Audit Initiation

• Establishing Initial Contact with the Auditee
• Determining Audit Feasibility
• Confirming Audit Objectives, Scope and Criteria
• Establishing Audit Arrangements

Module 19: Audit Preparation

• Reviewing Relevant QMS Information
• Developing the Audit Plan
• Preparing Audit Working Documents
• Allocating Time and Audit Responsibilities

ISO 9001 Lead Implementer Exam Information 

To achieve the ISO 9001 Lead Implementer, candidates will need to sit for an examination. The exam format is as follows: 

• Question Type: Multiple Choice 
• Total Questions: 30 
• Total Marks: 30 Marks 
• Pass Mark: 50%, or 15/30 Marks 
• Duration: 40 Minutes  
• Open Book/ Closed Book: Closed Book

Who Should Attend this ISO 9001 Lead Implementer Training?

This ISO 9001 Lead Implementer Training is suitable for professionals involved in quality management, auditing, compliance, and organisational improvement. It is particularly relevant to professionals responsible for supporting Quality Management System activities, including:

• Quality Managers
• Quality Assurance Managers
• Compliance Managers
• Internal Auditors
• Quality Management Professionals
• Process Improvement Managers
• Audit Programme Managers
• Operations Managers

Prerequisites for the ISO 9001 Lead Implementer Training

There are no formal prerequisites to attend this ISO 9001 Lead Implementer Training. However, prior knowledge of Quality Management Systems and ISO 9001 standards would be beneficial for delegates.

ISO 9001 Lead Implementer Training Overview

ISO 9001 Lead Implementer Training develops advanced knowledge of Quality Management System requirements and related auditing principles. It covers organisational context, leadership, planning, operations, evidence-based and risk-based auditing, audit programme management, and audit preparation.

Delegates will develop skills in evaluating audit evidence, identifying risks, establishing audit priorities, and understanding audit programme responsibilities. They will also gain knowledge of auditor competence, team coordination, audit initiation, and planning activities.

This 3-Day course offered by The Knowledge Academy helps delegates strengthen their understanding of ISO 9001 and Quality Management System activities. They will be better equipped to evaluate QMS requirements, support audit planning, assess evidence, and contribute to effective quality management practices.

ISO 9001 Lead Implementer Training Course Objectives

• To explain the key requirements and principles of ISO 9001
• To evaluate Quality Management System processes and audit evidence
• To apply evidence-based and risk-based auditing principles
• To plan audit programmes and determine suitable audit priorities
• To understand auditor competence, responsibilities, and team coordination
• To prepare audit activities by defining objectives, scope, criteria, and resources

Learning Outcomes of this ISO 9001 Lead Implementer Training

Upon completing this ISO 9001 Lead Implementer Training, delegates will understand key Quality Management System requirements and structured auditing approaches. They will also be able to evaluate audit evidence, identify audit risks, understand audit programme responsibilities, and support effective audit initiation and preparation activities.

What’s Included in this ISO 9001 Lead Implementer Training?

• ISO 9001 Lead Implementer Examination
• World-Class Training Sessions from Experienced Instructors
• ISO 9001 Lead Implementer Certificate
• Digital Delegate Pack